Trials / Completed
CompletedNCT02320981
Mucosal Impedance in Pediatric Population
Assessment of Esophageal Epithelium Integrity With Mucosal Impedance in Pediatric Patients
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 127 (actual)
- Sponsor
- Vanderbilt University Medical Center · Academic / Other
- Sex
- All
- Age
- 1 Year – 18 Years
- Healthy volunteers
- Accepted
Summary
Our hypothesis is that patients with GERD and/or Eosinophilic Esophagitis (EE) have lower esophageal impedance measurements when compared to patients who do not have GERD or EE.
Detailed description
The overall goal of this project is to develop and assess a novel, inexpensive, minimally invasive technology to detect mucosal damage based on mucosal conductivity changes in the pediatric population. The study is based on preliminary work between Sandhill Scientific, Inc. and our adult gastroenterology department. They have collaborated to create a novel, minimally invasive Mucosal Impedance (MI) test (proprietary technology) based on animal studies which have shown esophageal tissue exposed to acidic and weakly acidic injurious agents causes dilation of intercellular spaces and loss of tight junctions along the squamous epithelial lining of the esophagus and results in measurable decreased baseline impedance.9 Adult studies have confirmed the correlation between decreased impedance and diseased tissue, however this has not been studied in children. We hypothesize that pediatric patients with histologic damage seen in GERD and EoE will have mucosal changes resulting in decreased electrical impedance compared to those with normal histology. We propose that this technology will accurately and reliably measure the mucosal consequence of chronic esophageal exposure to injurious gastroduodenal agents or food allergens. Thus, this test would serve as a minimally invasive screening tool for GERD and EoE prior to endoscopy, and allow longitudinal monitoring of mucosal response to therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Standard of Care esophagogastroduodenoscopy (EGD) with measurement of mucosal impedance |
Timeline
- Start date
- 2014-08-01
- Primary completion
- 2016-09-01
- Completion
- 2016-09-01
- First posted
- 2014-12-19
- Last updated
- 2017-05-01
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02320981. Inclusion in this directory is not an endorsement.